ROCKSAUCE FIRE- methyl salicylate, menthol and capsaicin cream

rocksauce fire by

Drug Labeling and Warnings

rocksauce fire by is a Otc medication manufactured, distributed, or labeled by NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Methyl Salicylate 20%

Menthol USP 10%

Capsaicin 0.002%

Purpose

Topical Analgesic

Uses:

Provides soothing Cold to sore muscles and joints

Warnings:

For external use only.

Avoid contact with eyes, mucous membrane or broken skin

Keep out of reach of children.

if accidental ingestion, get medical help or call a Poison Control Center right away.

Directions:

Apply liberally to area of pain and massage unti lotion is absorbed into the skin. Repeat 3-4 times daily. Store at 68° to77°F (20°to 25°C).

When using this product

do not heat, microwave, and to hot water or any container where heating water may cause splattering and result in burns, use in eyes or directly on mucus membrans, take by mouth or place in nostrill, apply to wounds or damaged skin. Do not use otherwise than as directed

Consult a doctor and discontinus use.

if irritation occurs, ask a health professional before use if pregnant or brastfeeding. before using if you have sensitive skin.

Inactive ingredients:

Water, Aminomethyl Propanol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana Extract, Carbomer, Cetearl Alcohol, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Phenoxyethanol, Propylene Glycol, Tocopheryl Acetate

Principal Display Panel

INGREDIENTS AND APPEARANCE

ROCKSAUCE FIRE 
methyl salicylate, menthol and capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73344-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	20 mg  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 100 mL
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA (UNII: O80TY208ZW)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73344-103-01	1 in 1 PACKAGE	09/29/2019
1		88.7 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 73344-103-02	1 in 1 PACKAGE	09/29/2019
2		355 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/29/2019

Labeler - NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD (404080257)

Establishment
Name	Address	ID/FEI	Business Operations
NINGBO SANTE YING MEDICALAND HEALTHDEVELOPMENT CO.,LTD		404080257	manufacture(73344-103)